My client is a global OTC/Consumer Health organisation based in Mannheim who are looking to bring on a Head of Regulatory Affairs focusing solely on the DACH region. As part of the DACH leadership team, you will be responsible for establishing and maintaining regulatory, local safety, and medical affairs infrastructure to ensure relevant support in the region, leading a team of 2 employees and some external resources.
You will be a vital part of the DACH growth strategy as well as ongoing growth within your team.
Key Responsibilities:
* Leads the DACH regulatory function and builds an infrastructure to ensure regulatory support in the region, for affiliates and distributors.
* Ensures the creation of a structure that fulfills the responsibilities regarding Ownership, Technical Direction, Storage, and Distribution of medicines and health products within the European and regional legislative framework.
* Provides oversight of regulatory and medical-related launch and marketing activities in the region.
* Provides regulatory leadership, strategic guidance, and local execution for the entire portfolio which includes medicines such as herbals, medical devices, food supplements, and cosmetics for the region.
* Leads the preparation of DACH-specific documents for inclusion in submissions and label extensions.
* Ensures that the company’s products remain in regulatory compliance.
* Keeps abreast of new regulatory requirements and anticipates their future impact on the DACH region and the organization as a whole.
* Acts as the principal liaison with country competent authorities (e.g. BfArM) for original product approvals and maintenance, including negotiation and maintenance of labeling.
* Works closely with the global Regulatory Affairs team to develop and implement the global regulatory strategy for the company’s products.
* Active participation with relevant local Trade Associations.
* Participates as an active member of the DACH Leadership team defining and overseeing plans for the region.
* Prepares an annual budget and operates within that budget.
* Medical and Safety aspect:
* Acts as a medical expert and provides medical and scientific support to brand strategies, product claims, and promotional and non-promotional materials.
* Maintains a good working knowledge of the DACH healthcare market.
* Reviews and signs off promotional and non-promotional materials in line with local regulations and acts in the role of information officer.
* Develops and maintains relationships with Key Opinion Leaders and relevant authorities.
* Guarantees the proper operation of the local vigilance structure, fulfilling local responsibilities such as acting as “Stufenplanbeauftragter,” in compliance with national and regional regulatory requirements.
Experience and Professional Qualifications:
* University degree as a minimum; higher qualifications (MD, PhD, MBA) advantageous.
* Established regulatory/medical affairs leader with substantial industry experience in the (EU) healthcare markets, ideally in the DACH markets.
* Proven track record of directly leading the launch of new products through European and national procedures.
* Extensive experience with variation procedures for pharmaceuticals, both at the European and national levels.
* Extensive experience in the Medical Affairs field with a deep understanding of its roles, responsibilities, and cross-functional collaboration within the organization.
* Ideally experience as Informationsbeauftragter and Stufenplanbeauftragter.
* Strong understanding of the Medical Device Regulation (MDR), particularly the responsibilities of distributors.
* Knowledge of the legal requirements for food supplements and cosmetics.
* Demonstrated success in a startup environment with a hands-on and adaptable approach.
* Excellent leadership and team management skills.
* Must have a track record of success in adapting and thriving in an environment characterized by rapid changes and market dynamics.
* Demonstrated ability to make well-informed decisions quickly and efficiently in response to industry trends and competitive shifts.
* Hands-on experience in navigating the challenges of a constantly evolving landscape, showcasing resilience and strategic agility.
* Familiarity with the demands of fast-paced consumer markets and the ability to proactively align operations with dynamic industry requirements.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research and Science
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
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